Efficacy and Safety of a New Sperm Capacitation Method

Not yet recruiting

• Conditions: Reproductive Issues; Male Infertility; Asthenozoospermia; Oligozoospermia; Teratozoospermia

• Registration Number: NCT06742437
• Lead Sponsor: Fecundis Lab SL

Brief Summary

Prospective, multicenter research study with a split-sample design on semen samples, without intervention, to evaluate the efficacy and safety of HyperSperm, a new sperm capacitation method, in 300 semen samples with various characteristics and abnormalities, in an in vitro study over 12 months.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 300

Inclusion Criteria

• Ability to provide a semen sample via masturbation

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Exclusion Criteria

• Current diagnosis of a sexually transmitted infection (STI)
• Previous diagnosis of hepatitis A, B, C, D, or HIV
• Prior participation in this study
• Participation in a clinical trial involving an intervention within the last 3 months

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hyperactivation	2 hours	Percentage of sperm cells displaying hyperactivated motility

Secondary Outcome Measures

Name	Time	Method
Sperm vitality	2 hours	Percentage of viable sperm cells
DNA fragmentation	2 hours	Percentage of TUNEL-positive sperm cells
Sperm motility	2 hours	Percentage of motile sperm cells
Survival	20 hours	Percentage of motile sperm cells after overnight incubation

Trial Locations

Locations (4)

Eugin Barcelona; 🇪🇸 Barcelona, Spain

Fertty; 🇪🇸 Barcelona, Spain

CIRH; 🇪🇸 Barcelona, Spain

Natuvitro; 🇪🇸 Barcelona, Spain